Načela in smernice dobre proizvodne prakse je treba opredeliti v zvezi z upravljanjem kakovosti, osebjem, prostori in opremo, dokumentacijo, izdelavo, kontrolo kakovosti, pogodbenim delom, pritožbami in odpoklicem zdravil ter notranjim nadzorom.
Principles and guidelines of good manufacturing practice should be set out in relation to quality management, personnel, premises and equipment, documentation, production, quality control, contracting out, complaints and product recall, and self-inspection.